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    Summary
    EudraCT Number:2021-001243-27
    Sponsor's Protocol Code Number:77108
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-09-21
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedNetherlands - Competent Authority
    A.2EudraCT number2021-001243-27
    A.3Full title of the trial
    Effect of oral magnesium supplementation on insulin sensitivity in people with type 2 diabetes
    Effect van orale magnesium suppletie op de insulinegevoeligheid bij mensen met type 2 diabetes
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effect of magnesium intake on insulin sensitivity in people with type 2 diabetes
    Het effect van het innemen van magnesium op de gevoeligheid voor insuline bij mensen met type 2 suikerziekte
    A.3.2Name or abbreviated title of the trial where available
    Magnesium
    Magnesium
    A.4.1Sponsor's protocol code number77108
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1264-6218
    A.5.4Other Identifiers
    Name:PaNaMaNumber:111728
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorRadboudumc
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportRadboudumc
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRadboudumc
    B.5.2Functional name of contact pointInternal Medicine
    B.5.3 Address:
    B.5.3.1Street AddressGeert Grooteplein Zuid 10
    B.5.3.2Town/ cityNijmegen
    B.5.3.3Post code6525 GA
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31243618819
    B.5.6E-mailsecretariaatstaf.aig@radboudumc.nl
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameMagnesium gluconate oral solution 0.1 mmol/ml (ATC: A12CC03)
    D.3.4Pharmaceutical form Oral solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMagnesium gluconate (ATC A12CC03)
    D.3.9.1CAS number 3632-91-5
    D.3.9.3Other descriptive nameMAGNESIUM GLUCONATE
    D.3.9.4EV Substance CodeSUB14425MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mmol/ml millimole(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.1
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboOral solution
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    People with type 2 diabetes mellitus who are treated with insulin and have a low serum magnesium concentration
    Mensen met insuline-behandelde type 2 diabetes mellitus en een lage serum magnesium concentratie
    E.1.1.1Medical condition in easily understood language
    People with type 2 diabetes mellitus who are treated with insulin and have a low serum magnesium concentration
    Mensen met type 2 suikerziekte die behandeld worden met insuline en een lage magnesium concentratie in het bloed hebben
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate the effect of oral magnesium supplementation on insulin sensitivity in people with insulin-treated type 2 diabetes mellitus (T2DM) and a low serum magnesium concentration.
    Het effect van orale magnesium suppletie op de insuline gevoeligheid bij mensen met insuline-behandelde type 2 diabetes en een lage serum magnesium concentratie.
    E.2.2Secondary objectives of the trial
    • To investigate the effect of oral magnesium supplementation on insulin dose requirements
    • To investigate the effect of oral magnesium supplementation on symptoms associated with hypomagnesemia
    • To investigate the effect of oral magnesium supplementation on blood pressure
    • To investigate the effect of oral magnesium supplementation on HbA1c
    • To investigate the effect of oral magnesium supplementation on glucose profile
    • To investigate the effect of oral magnesium supplementation on physical activity
    • To investigate the effect of oral magnesium supplementation on lipid profile
    • To investigate the effect of oral magnesium supplementation on inflammatory profile (circulating inflammatory cells and inflammatory markers)
    • To explore the differences in HbA1c, lipid profile and blood pressure between people with T2DM with normo- and low serum magnesemium concentration
    * Het effect van orale magnesium suppletie op insuline dosis
    * Het effect van orale magnesium suppletie op symptomen geassocieerd met een hypomagnesiemie
    * Het effect van orale magnesium suppletie op de bloeddruk
    * Het effect van orale magnesium suppletie op het HbA1c
    * Het effect van orale magnesium suppletie op het glucoseprofiel
    * Het effect van orale magnesium suppletie op de lichamelijke activiteit
    * Het effect van orale magnesium suppletie op het lipidenprofiel
    * Het effect van orale magnesium suppletie op het inflammatieprofiel
    * Het verschil in HbA1c, lipidenprofiel en bloeddruk tussen mensen met T2DM en een normo- versus verlaagd serum magnesium
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Clinical diagnosis of T2DM
    • Treatment with insulin for at least one year
    • Minimum age of 18 years
    • Ability to provide informed consent
    * Type 2 diabetes mellitus
    * Behandeling met insuline sinds minimaal een jaar
    * Minimale leeftijd van 18 jaar
    * Vermogen om informed consent te verlenen
    E.4Principal exclusion criteria
    • Treatment with more than 7.5 mg prednisone daily (or a comparable dose of other oral corticosteroids)
    • Use of magnesium supplementation in the week before screening; people who are willing to stop magnesium supplementation for at least one week before the screening visit are still eligible for enrolment
    • Any cardiovascular event in the six months before screening
    • Illnesses and unstable diseases that interfere with the primary outcome
    • Chronic diarrhea
    • Alcohol consumption of more than 14 units weekly
    • MDRD-GFR < 45 ml/min/1.73m2
    • Body-Mass Index < 18 or > 40 kg/m2
    • Pregnancy or the wish to become pregnant
    * Behandeling met meer dan 7.5 mg prednison per dag (of een vergelijkbare dosis met een ander oraal corticosteroïd)
    * Gebruik van magnesium suppletie in de week voorafgaand aan de screening
    * Een cardiovasculair event in de 6 maanden voor de screening
    * (Instabiele) ziektes die interfereren met de primaire uitkomstmaat
    * Chronische diarree
    * Alcohol gebruik van meer dan 14 eenheden per week
    E.5 End points
    E.5.1Primary end point(s)
    The change in insulin sensitivity after oral magnesium supplementation measured by glucose infusion rates during a hyperinsulinemic euglycemic glucose clamp.
    De verandering in insuline gevoeligheid na orale magnesium suppletie bepaald aan de hand van de glucose infusiesnelheid gedurende een hyperinsulinemische euglykemische glucose clamp.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At the end of each treatment period
    Aan het einde van elke behandelingsperiode
    E.5.2Secondary end point(s)
    • Glycemic control measured at screening and before both clamps by fasting plasma glucose
    • Glycemic control measured at screening and before both clamps by HbA1c
    • Differences in insulin dose and dosage of other glucose lowering drugs between the study visits
    • Symptoms of hypomagnesemia using a questionnaire at screening and at the final day of each treatment period
    • Blood pressure measured by automated blood pressure monitoring during 30 minutes at screening and at one week before the clamps
    • Time in range measured by blinded continuous glucose monitoring in the final week of each treatment period
    • Activity profile using an activity tracker during the final week of each treatment period
    • Lipid profile including measured at screening and at the final day of each treatment period
    • Inflammatory profile measured by circulating immune cells and cytokines at the final day of each treatment period
    • Differences in HbA1c between people with T2DM with normo- and hypomagnesemia
    • Differences in lipid profile between people with T2DM with normo- and hypomagnesemia
    • Differences in blood pressure between people with T2DM with normo- and hypomagnesemia
    * Glucose instelling gemeten bij screening en voor beide clamps middels nuchter glucose
    * Glucose instelling gemeten bij screening en voor beide clamps middels HbA1c
    * Verschil in insulinedosering en dosering van andere glucoseverlagende medicijnen tussen de onderzoeksdagen
    * Symptomen passend bij hypomagnesiemie gescoord middels een vragenlijst, afgenomen tijdens de screening en op de laatste dag van elke behandelperiode
    * Bloeddruk gemeten middels automatische bloeddrukmeting gedurende 30 minuten tijdens de screening en een week voor beide clamps
    * De tijd in euglykemie gemeten middels een geblindeerde continue glucosesensor in de laatste week van elke behandelperiode
    * Activiteitenprofiel gemeten middels een activiteitenmeter in de laatste week van elke behandelperiode
    * Lipidenprofiel gemeten bij screening en voor beide clamps
    * Inflammatie profiel (immuuncellen en cytokines) op de laatste dag van elke behandelperiode
    * Verschil in HbA1c tussen mensen met T2DM en een normo- vs hypomagnesiemie
    * Verschil in lipidenprofiel tussen mensen met T2DM en een normo- vs hypomagnesiemie
    * Verschil in bloeddruk tussen mensen met T2DM en een normo- vs hypomagnesiemie
    E.5.2.1Timepoint(s) of evaluation of this end point
    At the end of each treatment period
    Aan het einde van elke behandelingsperiode
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 14
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 14
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state14
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    Geen
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-09-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-12-09
    P. End of Trial
    P.End of Trial StatusCompleted
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